Chemical Policy
Chemical Policy
Newton, NJ 07860
United States
Purpose
The purpose of this policy is to outline chemical-related requirements to meet regulation and
certification standard compliance, and to ensure that chemical handling does not adversely
affect finished product quality or safety.
Policy
Partner Facilities approve, purchase, and use chemicals in accordance with chemical labeling
recommendations, intended usage, and all applicable regulatory requirements, including but not
limited to State, EPA, FDA, and OSHA. Partner Facilities ensure that all chemicals stored and
utilized onsite do not present food safety and quality risks to products, packaging, or food
contact surfaces. Requirements in place to ensure this is met include:
Chemical Approval: Partner Facilities’ Management (if applies), Purchasing, and Quality
Assurance approve chemicals prior to purchase and use. Approval varies per chemical type and
usage location. Approval requires gathering pertinent documentation, ensuring regulatory
compliance, and documenting/recording the approval of a chemical. The approval process, for
larger factories, may include multiple parties as determined by the factory.
Process Aids: Processing aids are not present in final product in significant amounts; thus,
ingredient labeling is not required. Processing aids are approved in consideration of the
requirements outlined in Policy 6.1 Specification Management to ensure regulatory compliance.
In addition, the following documentation must be available for the approval process:
• GMP Area Equipment Chemicals: Chemicals utilized in GMP areas include but are not
limited to grease (lubricant), silicone, mineral oil, etc. The following documentation must
be available for the approval process:
• Technical Data Sheet
• Safety Data Sheet
• Food Grade Statement, CFR Citation, or Food Grade Labeling Printed on Container
• Allergen Status Letter
General Chemicals: General, non-process aid chemicals utilized throughout the factory in non-
GMP areas require safety data sheets only.
Prohibited Chemicals: Partner Facilities do not purchase or use chemicals banned by the FDA
as outlined in 21 CFR 189.
Chemical Register & Inventory: Partner Facilities maintain a list of approved chemicals
purchased, stored, and used on their premises. Chemical inventories for point-of-use chemicals
and point-of-use storage areas are not required.
Chemical Labels & Secondary Containers: Chemicals are stored in their original containers with
original labeling. Exceptions include bulk chemicals and chemicals requiring secondary
containers for use e.g., grease guns, spray bottles, and pails. Secondary containers are legibly
labeled to prevent cross contact between food grade and non-food grade chemicals. Where
applicable and according to Safety requirements, containers are labeled with National Fire
Protection Association (NFPA) diamond or GHS labeling practices in addition to the common
name.
Chemical Storage: Facility Management ensures that chemicals are stored properly based on
chemical type. Chemical storage areas in GMP-rated areas are secured and restrict
unauthorized access. All chemicals are stored away from packaging, ingredients, and finished
products. Storage based on chemical type include the following elements:
Food Grade: Food grade chemicals are stored in designated, labeled areas. Food grade
chemical storage is segregated from non-food grade chemical storage. Food grade and non-
food grade chemicals may be stored in the same cabinet provided there is physical separation
and protection from cross contact e.g., top shelf or interior compartments.
Non-Food Grade: Non-food grade chemicals are required to be stored in designated, labeled
areas.
Hazardous: Chemicals that are classified as hazardous meet all non-food grade requirements
and all additional requirements outlined below:
Responsibility
Quality Assurance Team: Responsible for interpretation of FDA law, certification standards, and
their application to Company policies. Responsible for verifying GMP and prerequisite program
compliance.
Quality Assurance Manager & Purchasing Departments: Responsible for chemical approval and
obtaining required documentation prior to purchasing. Quality is responsible verifying chemical
control programs.